AB1523-HPR USABILITY AND ACCEPTABILITY OF A NEW AUTOINJECTOR DEVICE AND ITS ASSOCIATED APP IN AUSTRALIAN, FRENCH, GERMANY AND JAPANESE RHEUMATOLOGY PATIENTS
Authors: R. Alten, M. Latymer, D. C. Gruben, L. Gunther-Lavergne, S. Moss, H. Kameda
Journal: Annals of the Rheumatic Diseases (2022)

Background Smartclic/ClicWise is a new reusable autoinjector with a dose-dispensing cartridge for subcutaneous self-administration of biotherapeutics in development for patients with rheumatoid arthritis (RA) and other diseases. The device can connect to an optional mobile phone app (Smartclic, or ClicNote in Japan) to aid in tracking injections and other treatment or symptom data. Objectives The study objective was to collect ease of use and usability data on the Smartclic injector and companion app from experienced patients. Methods After completing a patient profiling questionnaire, adult patients (≥18 yrs) from Australia, France, Germany, and Japan with RA, psoriatic arthritis, or an original diagnosis of juvenile idiopathic arthritis who were prescribed an injectable biologic were enrolled in this study. For Japan, only patients with RA were enrolled. Each patient received training individually on the use of the Smartclic injector device and insertable cartridge and gained experience by performing simulated injections. Participants completed a questionnaire with evaluations of the device categories (number of questions): ‘ease of use’ (14), ‘usability effectiveness’ (11), ‘benefit of features’ (8), and ‘form factor’ (7). Participants also separately received a storyboard presentation summarizing the key features of the app, during which patients could explore the app (on a phone with either an android or iOS operating system), and completed 16 questions on the connectivity, usability, and benefit. Responses were recorded as Likert scale ratings from 1 (‘extremely negative’) to 7 (‘extremely positive’). Respondents also provided an estimate of patient training time for the device. Mean values were reported. The percentage of negative (Likert scale rating 1-2), neutral (3-5), and positive (6-7) responses for each category were determined. Results A total of 139 patients (mean age [range], 52 [18-84] yrs; 73% female) participated in the study (Table 1). Mean scores (percentage of positive responses) for the device were: ease of use 6.43 (86.2%), usability effectiveness 6.39 (86.5%), benefit of features 6.46 (89.4%), form factor 6.10 (77.2%); and 6.06 (74.2%) for connectivity and benefit of the app (Figure 1). Mean estimated time for training a patient to effectively use the device/cartridge was just under 9.5 min (range, 0-30 min). Table 1. Participant characteristics Characteristic Patients (N=139 ) Sex, n (% ) Male 38 (27) Female 101 (73) Mean age (range), yrs 52 (18-84) Age groups, n (% ) 18-30 yrs 11 (8) 31-59 yrs 85 (61) &gt;60 yrs 43 (31) Diagnosis, n (% ) Rheumatoid arthritis 104 (75) Psoriatic arthritis 34 (24) Juvenile idiopathic arthritis* 1 (1) Handedness, n (% ) Right-handed 128 (92) Left-handed 9 (6) Ambidextrous 2 (1) *Originally diagnosed with juvenile idiopathic arthritis, but now aged ≥18 yrs. Conclusion Rheumatology patients responded positively on the new autoinjector device and app across all categories, indicating its suitability for self-administration of biotherapeutics. Acknowledgements Medical writing support was provided by Jacob Evans, of Engage Scientific Solutions. Disclosure of Interests Rieke Alten Consultant of: AbbVie, Bristol-Myers Squibb, Gilead, Lilly, Novartis, Pfizer and UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Galapagos, Gilead, Janssen, Lilly and Pfizer, Mark Latymer Shareholder of: Pfizer, Employee of: Pfizer, David C Gruben Shareholder of: Pfizer, Employee of: Pfizer, Lisa Gunther-LaVergne Employee of: Farm Design, Simon Moss Shareholder of: Pfizer, Employee of: Pfizer, Hideto Kameda Speakers bureau: AbbVie, Asahi-Kasei, Bristol-Myers Squibb, Chugai, Eisai, Janssen, Lilly, Mitsubishi-Tanabe, Novartis and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Sanofi and UCB, Grant/research support from: AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Eisai and Mitsubishi-Tanabe